Novartis’ Xolair approved by NICE for chronic spontaneous urticaria

Novartis has welcomed the National Institute of Health and Care Excellence's (NICE's) decision to approve its drug Xolair as a treatment for chronic spontaneous urticaria (CSU).

The UK regulator has recommended the drug for use as an add-on therapy for treating severe CSU for adults and young people across England who have not responded to treatment with H1-antihistamines and leukotriene receptor antagonists.

It is the first new type of medicine licensed for the treatment of CSU since the 1950s and should be made available to NHS patients from this summer, barring an appeal. The regulator approved Xolair for this indication based on its speedy efficacy and safety.

During three placebo-controlled clinical trials, the drug was shown to significantly improve itching and hives, and in many cases completely cleared symptoms.

Dr Sinisa Savic, consultant immunologist at St James' University Hospital in Leeds, said: "For many years, treatment options for patients with the severe form of CSU have been quite limited and there has been a real medical need for an effective, licensed medicine to be available to patients and clinicians."

This comes after the firm's lung cancer therapy Zykadia was recommended for EU approval by the European Medicines Agency's Committee for Medicinal Products for Human Use earlier this month.